Apparatus for electrolyzing fluids

ABSTRACT

An apparatus for electrolyzing fluids is disclosed. The resulting electrolyzed fluids are particularly suited for treating physiological materials such as whole blood, plasma, or cell isolates in order to reduce the effect of harmful microorganisms. A container holds the fluid and a power supply provides a source of electrical current to an anode and a cathode positioned within the container. The anode comprises a base material selected from titanium and niobium. An outer layer of platinum is bonded to the base. The anode comprises a cylindrical shape. The cathode is also connected to the power supply and comprises titanium and has a substantially cylindrical shape. The cathode is positioned concentrically in relation to the anode. The spacing between the cathode and the anode is not greater than a preferred amount. Moreover, the voltage potential between the cathode and the anode is not greater than a preferred amount.

BACKGROUND

1. The Field of the Invention

This invention relates to apparatus and methods for electrolyzing fluidsand more particularly relates to apparatus and methods for electrolyzingsaline solutions for use in medical treatments.

2. The Prior Art

It has long been known that the electrolysis of fluids can result inuseful products. In particular, the electrolysis of saline solutionresults in the production of chlorine and ozone. It is known that theproducts resulting from the electrolysis of saline solutions are invitro microbicides for hard surfaces. Thus, various apparatus andmethods have been proposed for electrolyzing saline solution, however,all of the previously available schemes present one or more drawbacks.

For example, U.S. Pat. Nos. 4,236,992 and 4,316,787 to Themy disclose anelectrode, method and apparatus for electrolyzing dilute salinesolutions to produce effective amounts of disinfecting agents such aschlorine, ozone and hydroxide ions. One apparatus for producingelectrolyzed saline solutions was previously available under the tradename Ster-O-Lizer. Laboratory reports and other data available fromtesting of electrolyzed saline solutions from various Ster-O-Lizermodels have shown that it is effective in keeping water free ofpathogenic organisms. Tests conducted in vitro further show that certainmicroorganisms, inclusive of Pseudomonas aeruginosa, Escherichia coli,Staphylococcus aureus, Candida albicans, and Salmonella typhi, arenon-infectious after exposure to electrolyzed saline solutions.

For many years, ozone (O₃) has been used for the treatment of viralinfections. Chlorine, in the form of chlorinated lime, was usedsuccessfully as early as 1846 to prevent and fight puerperal fever. By1911, the United States purified as much as 800,000,000 gallons of waterthrough the chlorination process. Wide use of chlorine as a 0.05% sodiumhypochlorite solution (Dakins Solution) for open and infected woundsbegan in 1915. Dakins Solution was a standard product up to 1963 listedin the British Pharmacopeia.

As reported by Wilk et al., International Congress on Technology andTechnology Exchange, First Euro-American Symposium, Paris, France (1992)and Science, Total Environment, 63:191-197 (1987), certain combinationsof ozone and chlorine have significantly greater activity than eitherused separately against a variety of bacteria including Staphylococcusaureus and Pseudomonas aeruginosa. Candida albicans was also reported tobe effectively killed by a combination of ozone and chlorine.

In view of the many uses of chlorine and ozone, numerous apparatus andmethods have been proposed for generating chlorine and ozone.Significantly, the previously available apparatus and methods have notbeen well-suited to producing electrolyzed saline containing finiteamounts of ozone and chlorine for treatment of physiological fluids forthe destruction of microbes in warm blooded animals. It has recentlybeen discovered that there are situations where physiological fluids canbe beneficially treated using electrolyzed saline solutions. Thetreatment of physiological fluids such as whole blood, plasma or cellisolates by electrolyzed saline solution which renders them benign frominfectious organisms without destroying the therapeutic characteristicsof such fluids is now possible. Disadvantageously, the availableapparatus and methods for generating chlorine and ozone are notwell-suited for treatment of physiological fluids such as whole blood,plasma, or cell isolates.

Methods for treatment of physiological fluids using electrolyzedsolutions are set forth in U.S. patent application Ser. Nos. 07/527,321filed May 23, 1990 (now U.S. Pat. No. 5,334,383 issued Aug. 2, 1994) and08/275,904 filed Jul. 15, 1994, all of which are now incorporated hereinby reference in their entireties. In these documents, an electrolyzedsaline solution, properly made and administered in vivo, is effective inthe treatment of various infections brought on by invading antigens andparticularly viral infections. Thus, it would be a great advance in theart to provide an apparatus and method for electrolyzing saline solutionfor administration in vivo.

BRIEF SUMMARY AND OBJECTS OF THE INVENTION

In view of the above described state of the art, the present inventionseeks to realize the following objects and advantages.

It is an object of the present invention to provide an apparatus andmethod for electrolyzing saline solutions which are particularlysuitable for administration in vivo.

It is also an object of the present invention to provide an apparatusand method for electrolyzing fluids which does not introduce harmfulsubstances into the fluid.

It is a further object of the present invention to provide an apparatusand method for electrolyzing saline solutions which is reliable and canbe economically operated.

These and other objects and advantages of the invention will become morefully apparent from the description and claims which follow, or may belearned by the practice of the invention.

The present invention provides and an apparatus for electrolyzingfluids. The resulting electrolyzed fluids, such as a saline solution,are particularly suited for treating physiological materials such aswhole blood, plasma or cell isolates in order to reduce the effect ofharmful microorganisms.

A preferred embodiment of the present invention includes a containermeans for holding a fluid which is to be electrolyzed. A power supplymeans provides a source of electrical current. At least a first anodeand a second anode are connected to the power supply means. The anodesand cathodes are positioned within the container means so as to beimmersed in the fluid to be electrolyzed.

The anode comprises a base metal. The base metal is a metal selectedfrom the group consisting of titanium and niobium. An outer layer ofplatinum is bonded to the base. The anode comprises a cylindrical shape.

The cathode is also connected to the power supply means. The cathodepreferably comprises titanium or niobium and also has a substantiallycylindrical shape. The cathode is positioned concentrically in relationto the anode. The spacing between the cathode and the anode is notgreater than a preferred amount. Moreover the voltage; potential betweenthe cathode and the anode is not greater than a preferred amount.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better appreciate how the above-recited and other advantagesand objects of the invention are obtained, a more particular descriptionof the invention briefly described above will be rendered by referenceto specific embodiments thereof which are illustrated in the appendeddrawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be consideredlimiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 is a perspective view of a first presently preferred embodimentof the present invention.

FIG. 2 is a detailed top view of the electrode assembly represented inFIG. 1.

FIG. 3 is a side cross sectional view of the electrode assembly takenalong line 3--3 in FIG. 2.

FIG. 4 is a block diagram of a second presently preferred embodiment ofthe present invention.

FIG. 5 is a top view of an electrode assembly preferred for use in theapparatus represented in FIG. 4.

FIG. 6 is a cross sectional view taken along line 6--6 of FIG. 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made to the drawings wherein like structures willbe provided with like reference designations.

Referring first to FIG. 1, which is a perspective view of a firstpresently preferred embodiment of the present invention generallyrepresented at 100, includes a power supply 102 and a fluid receptaclerepresented at 104. The fluid receptacle 104 includes a base 114 uponwhich is attached a fluid vessel 116. The base 114 can preferably befabricated from an insulative plastic material. The fluid vessel 116 ispreferably fabricated from an inert clear plastic material which iscompatible with biological processes as available in the art.

A lid 118 is provided to cover the fluid vessel 116 and keepcontaminants out of the fluid vessel 116. A screen 120 is positioned toprevent foreign objects, which might accidentally fall into the fluidvessel 116, from falling to the bottom of the fluid vessel 116. Thesaline solution which is to be treated is placed into the fluid vessel116, and the lid 118 placed, for the necessary period of time afterwhich the electrolyzed saline solution can be withdrawn from the fluidvessel 116, for example into a syringe, for use. The fluid vessel 116 issealed at its bottom by a floor 124 which is attached to the interior ofthe base 114.

An electrode assembly, generally represented at 122, is attached to thefloor 124 so that any fluid in the fluid vessel is exposed to theelectrode assembly 122. The electrode assembly 122 is electricallyconnected to the power supply 102 via terminals 110 and 112 and cables106 and 108, respectively. The power supply 102 should deliver acontrolled voltage and current to the electrode assembly 122 when fluidis placed into the fluid vessel 116. The voltage and current applied tothe electrode assembly 122 will vary according to the fluid beingelectrolyzed. A control for setting and measuring the voltage 102A and acontrol for setting and measuring the current 102B is provided in thepower supply. In accordance with the present invention, a low voltage ofless than about 30 volts DC is used. Exemplary voltage and currentvalues, and the advantages which accrue when using the preferred voltageand current values, will be explained shortly.

FIG. 2 is a top view of the electrode assembly 122 represented inFIG. 1. The electrode assembly 122 preferably comprises a cylindricalinner electrode 128 and a cylindrical outer electrode 126. The innerelectrode 128 is preferably solid or any hollow in the inner electrodeis sealed so that fluid does not enter any such hollow. The cylindricalshape of the inner electrode 128 and the outer electrode 126 ispreferred and results in better performance than obtained withelectrodes of other shapes, e.g., elongated flat panels.

The diameter A of the inner electrode 128 is preferably about one-halfinch but the diameter A of the inner electrode can be selected by thoseskilled in the art in accordance with the particular application for theelectrode using the information contained herein. The outer electrode126 should be of a generally cylindrical shape and preferably befabricated from titanium or niobium having a thickness (indicated at Bin FIG. 2) which ensures that the inner electrode is shielded frompotentially physical damage. As will be appreciated, titanium andniobium provide the advantage of resistance against corrosion whichfurther prevents the introduction of harmful substances into the fluidbeing electrolyzed.

Still referring to FIG. 2, the space, indicated at C, between the innerelectrode 128 and the outer electrode 126 does not exceed a maximumvalue. In contrast to previously available devices which separate theelectrodes by greater distances and then utilize higher voltages toobtain the desired electrolyzation, the present invention keeps theelectrode spacing small and obtains improved performance over otherschemes. It is preferred that the space between the inner electrode 128and the outer electrode 126 be not more than about one-half (1/2) inch;it is more preferred that the space between the inner electrode 128 andthe outer electrode 126 be not more than about three-eights (3/8) inch;and, it is most preferred that the space between the inner electrode 128and the outer electrode 126 be not more than about one-quarter (1/4)inch.

Reference will next be made to FIG. 3 which is a side cross sectionalview of the electrode assembly taken along line 3--3 in FIG. 2. As seenin FIG. 3, the outer electrode 126 extends above the inner electrode 128to provide improved electrical performance and physical protection. Theouter electrode 126 is attached to the floor 124 by way of bolts 130,which extend through bores provided in the floor 124, and accompanyingnuts. An electrical connection is made to the outer electrode 126 by alead 136 attached to the bolt and nut. The lead 136 is attached to oneof the terminals 110 or 112. Similarly, an electrical connection is madeto the inner electrode 128 by a lead 134 which is held in place by a nutattached to a threaded stud extending from the bottom of the innerelectrode and through a bore provided in the floor 124. The lead 134 isattached to the remaining one of the terminals 110 or 112. The leads 134and 136 are kept insulated from any fluid which is present in the fluidvessel 116.

It is preferred that the inner electrode 128 function as the anode whilethe outer electrode function as the cathode when electrolyzing fluidsand the power supply 102 and the terminals 110 and 112 should beproperly arranged to carry this out.

It is recognized in the art that the anode is subject to destructiveforces during electrolysis. In the prior art, the anode of an electrodeassembly may dissolve to the point of being inoperative and may need tobe replaced very often. Critically, as the anode of an electrodeassembly dissolves, the metallic components of the anode are dispersedinto the fluid. If the fluid is a saline solution which will be used totreat physiological fluids, toxic substances dispersed into thesolution, such as the materials comprising the anode, may be harmful ordangerous to the person who expects to be benefitted from the treatment.

Of all the possible materials for fabrication of the anode, the artrecognizes that platinum is the least likely to be dissolved when usedas an anode. Unfortunately, the cost of platinum precludes the use of ananode which consists entirely of platinum. Thus, it is common in the artto utilize another metal as a base for the anode with a layer ofplatinum being placed on surfaces which contact the fluid to beelectrolyzed.

The present invention advantageously utilizes an inner electrode 128,i.e., an anode, which includes a base of titanium, and even morepreferably niobium (also known as columbium), upon which a layer ofplatinum is provided wherever fluid contacts the anode. Significantly,niobium is a relatively good electrical conductor having a conductivitywhich is about three times greater than the conductivity of titanium.Moreover, if the base metal is exposed to the fluid, such as if apinhole defect develops, toxic products are not produced by the contactbetween niobium and the fluid. Moreover, the high breakdown voltage insaline solution of the oxide which forms when a niobium base receives alayer of platinum provides further advantages of the present invention.

Upon a base of niobium, a layer of platinum is formed on the anode. Thelayer of platinum is preferably formed using a technique referred to inthe art as brush electrodeposition which can be carried out by thoseskilled in the art using the information set forth herein. Othertechniques can also be used to form the platinum layer, such as tank(immersion) electrodeposition, vapor deposition, and roll bonding, butbrush electrodeposition is preferred because of its superior adhesionand resulting less porosity than other economically comparabletechniques.

The thickness of the platinum layer is preferably greater than about0.02 mils and is most preferably greater than about 0.06 mils, and up toabout 0.20 mils. The combination of using niobium as a base for theanode of the electrode assembly and utilizing brush electrodepositionprovides that the platinum layer can be much thinner than otherwisepossible and still provide economical and reliable operation. It will beappreciated by those skilled in the art, that even with an anodefabricated in accordance with the present invention replacement of theanode, which preferably comprises the inner electrode 128 represented inFIG. 3, may be necessary after a period of use. The construction of theembodiments of the present invention facilitate replacement of the innerelectrode 128 and the outer electrode 126 when it becomes necessary.

Represented in FIG. 4 is a block diagram of a second presently preferredembodiment, generally represented at 150, of the present invention. Theembodiment represented in FIG. 4 is particularly adapted for treatinglarge quantities of saline solution. Represented in FIG. 4 is a tank 152in which the saline solution is electrolyzed. An electrode assembly 154is provided in the tank and is preferably immersed into the solution. Apower supply 158, capable of providing sufficient current at the propervoltage, is connected to the electrode assembly via a cable 160.

Also represented in FIG. 4 is a circulation device 156 which optionallyfunctions to circulate the solution within the tank 152. A sensor 162 isalso optionally provided to measure the progress of the electrolyzationof the solution in the tank 152, for example by measuring the pH of thesolution. The sensor may preferably be an ion selective electrode whichcan be chosen from those available in the art. Other sensors, forexample chlorine, ozone, and temperature sensors, may also be includedwithin the scope of the present invention. A control unit 164 isoptionally provided to coordinate the operation of the power supply 158,the circulation device 156, and the sensor 162 in order to obtain themost efficient operation of the apparatus 150.

It will be appreciated that devices such as power supply 158,circulation device 158, sensor 162, and control unit 164 can be readilyobtained from sources in the industry and adapted for use withembodiments of the present invention by those skilled in the art usingthe information contained herein. In particular, the control unit 164 ispreferably a digital microprocessor based device accompanied byappropriate interfaces all allowing for accurate control of theoperation of the apparatus 150. It is also within the scope of thepresent invention to include structures to prevent contamination of thetreated solution by contact with nonsterile surfaces and by airbornepathogens both during treatment and while the fluid is being transferredto the apparatus and being withdrawn from the apparatus.

Reference will next be made to FIGS. 5 and 6 which are a top view andcross sectional view, respectively, of an electrode assembly, generallyrepresented at 154, which is preferred for use in the apparatusrepresented in FIG. 4. As can be seen best in FIG. 5, the electrodeassembly 154 includes a plurality of concentrically arranged anodes andcathodes. The cylindrical shape and concentric arrangement of theelectrodes represented in FIG. 5 provides for the most efficientoperation. The number of electrodes which are included can be selectedaccording to the application of the apparatus. For example, the numberof electrodes may be six, seven, eight, the eleven represented in FIGS.5 and 6, or more.

In FIG. 5, electrodes 170, 174, 178, 182, 186, and 190 preferablyfunction as cathodes and are preferably fabricated in accordance withthe principles set forth above in connection with the outer electroderepresented at 126 in FIGS. 1-3. Furthermore, in FIG. 5 electrodes 172,176, 180, 184, and 188 function as anodes and are preferably fabricatedin accordance with the principles set forth above in connection with theinner electrode represented at 128 in FIGS. 1-3.

In the cross sectional side view of FIG. 6 a plurality of tabs extendfrom the cylindrical electrodes 170, 172, 174, 176, 178, 180, 182, 184,186, and 190 to facilitate making an electrical connection thereto.Provided below in Table A are the relationship between the tabsillustrated in FIG. 6 and the electrodes.

                  TABLE A                                                         ______________________________________                                        Electrode   Tab              Function                                         ______________________________________                                        170         170A             Cathode                                          172         172A             Anode                                            174         174A             Cathode                                          176         176A             Anode                                            178         178A             Cathode                                          180         180A             Anode                                                        (Not                                                                          illustrated in                                                                FIG. 6)                                                           182         182A             Cathode                                          184         184A             Anode                                            186         186A             Cathode                                          188         188A             Anode                                                        (Not                                                                          illustrated in                                                                FIG. 6)                                                           190         190A             Cathode                                          ______________________________________                                    

Using the tabs 170A, 172A, 174A, 176A, 178A, 180A, 182A, 184A, 186A,188A, and 190A, those skilled in the art can provide the necessaryelectrical connections to the electrodes 170, 172, 174, 176, 178, 180,182, 184, 186, and 190 and can also provide numerous structures toprevent contact between the tabs and the fluid to be treated. Each ofthe tabs illustrated in FIG. 6 are provided with an aperture, such asthose represented at 172B, 176B, and 184B, which receive a wiringconnector.

While the apparatus described herein has many uses, the most preferreduse of the apparatus described herein is subjecting sterile salinesolution to electrolysis. The electrolyzed saline solution can then beused to treat a patient. The saline solution preferably has an initialconcentration in the range from about 0.25% to about 1.0% NaCl which isabout one-fourth to full strength of normal or isotonic saline solution.According to Taber's Cyclopedic Medical Dictionary, E. A. Davis, Co.1985 Ed., an "isotonic saline" is defined as a 0.16 M NaCl solution orone containing approximately 0.95% NaCl; a "physiological salt solution"is defined as a sterile solution containing 0.85% NaCl and is consideredisotonic to body fluids and a "normal saline solution;" a 0.9% NaClsolution which is considered isotonic to the body. Therefore, the terms"isotonic," "normal saline," "balanced saline," or "physiological fluid"are considered to be a saline solution containing in the range fromabout 0.85% to about 0.95% NaCl. Moreover, in accordance with thepresent invention, a saline solution may be subjected to electrolysis atconcentrations in the range from about 0.15% to about 1.0%.

It is preferred that one of the above described saline solutions bediluted with sterile distilled water to the desired concentration,preferably in the range from about 0.15% to about 0.35% prior totreatment in accordance with the present invention. This dilute salinesolution is subjected to electrolysis using the embodiments of thepresent invention at a voltage, current, and time to produce anappropriately electrolyzed solution as will be described shortly. It ispresently preferred to carry out the electrolysis reaction at ambienttemperatures.

The voltage and current values provided herein are merely exemplary andthe voltage and current values which are used, and the time the salinesolution is subject to electrolysis, is determined by many variables,e.g., the surface area and efficiency of the particular electrodeassembly and the volume and/or concentration of saline solution beingelectrolyzed. For electrode assemblies having a different surface area,greater volumes of saline solution, or higher concentrations of salinesolutions the voltage, current, or time may be higher and/or longer thanthose exemplary values provided herein. In accordance with the presentinvention, it is the generation of the desired concentration of ozoneand active chlorine species which is important. Electrolyzation of thesaline solution also results in other products of the electrolysisreaction including members selected from the group consisting ofhydrogen, sodium and hydroxide ions. It will be appreciated that theinteraction of the electrolysis products results in a solutioncontaining bioactive atoms, radicals or ions selected from the groupconsisting of chlorine, ozone, hydroxide, hypochlorous acid,hypochlorite, peroxide, oxygen and perhaps others along withcorresponding amounts of molecular hydrogen and sodium and hydrogenions.

According to Faraday's laws of electrolysis, the amount of chemicalchange produced by a current is proportional to the quantity ofelectrons passed through the material. Also, the amounts of differentsubstances liberated by a given quantity of electrons are proportionalto the chemical equivalent weights of those substances. Therefore, togenerate an electrolyzed saline having the desired concentrations ofozone and active chlorine species from saline solutions having a salineconcentration of less than about 1.0%, voltage, current, and timeparameters appropriate to the electrodes and solution are required toproduce an electrolyzed solution containing in the range from about 5 toabout 100 mg/L of ozone and a free chlorine content in the range fromabout 5 to about 300 ppm. For in vitro use these solutions can beutilized without further modification or they can be adjusted as desiredwith saline or other solutions. Prior to in vivo use, the resultingsolution may be adjusted or balanced to an isotonic saline concentrationwith sufficient hypertonic saline, e.g., 5% hypertonic saline solution.

In general, the electrolyzed solutions produced using the apparatusdescribed herein, which are referred to as microbicidal solutions, willhave an ozone content in the range from about 5 to about 100 mg/L and anactive chlorine species content in the range from about 5 to about 300ppm. More preferably the ozone content will be in the range from about 5to about 30 mg/L and the active chlorine species content will be in therange from about 10 to about 100 ppm. Most preferably the ozone contentwill be in the range from about 9 to about 15 mg/L and the activespecies content will be in the range from about 10 to about 80 ppm. Byactive chlorine species is meant the total chlorine concentrationattributable to chlorine content detectable by a chlorine ion selectiveelectrode and will be selected from the group consisting of chlorine,hypochlorous acid and hypochlorite ions or moieties.

The pH of the solution is preferably in the range from about 7.2 toabout 7.6 and, when used for intravenous administration, most preferablyin the range from about 7.35 to about 7.45 which is the pH range ofhuman blood. An effective amount of the resulting balanced microbicidalsaline solution is administered by appropriate modes, e.g.,intravenously, orally, vaginally or rectally and may vary greatlyaccording to the mode of administration, condition being treated, thesize of the warm-blooded animal, etc.

Particular dosages and methods of administration, as well as additionalcomponents to be administered, can be determined by those skilled in theart using the information set forth herein and set forth in the U.S.patent documents previously incorporated herein by reference. Asexplained in the cited U.S. patent documents, although it is known thatelectrolyzed saline solutions possess in vitro microbicidal activity ithas long been thought that components in the electrolyzed solution, suchas ozone and chlorine, are toxic to warm blooded animals and should notbe utilized for in vivo purposes. It has now been found, however, thatsaline solutions, which have been subjected to electrolysis to producefinite amounts of ozone and active chlorine products, can be injectedinto the vascular system to create a reaction to assist in the removal,passivation, or destruction of a toxin.

In order to arrive at the preferred end product, electrolyzed salinesolution using the apparatus illustrated in FIGS. 1-3, about a 0.33%(about one third physiologically normal) saline solution is placed inthe fluid vessel 116 (FIG. 1) and the apparatus is operated for about 5to 15 minutes with a voltage between the electrodes being maintained inthe range from about 10 volts to about 20 volts with a current flowmaintained in the range from about 5 to about 20 amps.

As one example of the use of the embodiment of FIGS. 1-3, a 0.225%saline solution is subjected to a current of 3 amperes at 20 volts (DC)for a period of three minutes. A 17 ml portion of this electrolyzedsolution is aseptically diluted with 3 mls of a sterile 5% salineresulting in a finished isotonic electrolyzed saline having an activeozone content of 12±2 mg/L and an active chlorine species content of60±4 ppm at a pH of 7.4.

It will be appreciated that the low voltages used in accordance with thepresent invention are preferably not greater than forty (40) volts DC oran equivalent value if other than direct current is used. Morepreferably, the voltages used in accordance with the present inventionis not more than about thirty (30) volts DC. The use of low voltagesavoids the problem of production of undesirable products in the fluidwhich can result when higher voltages are used. In accordance with thepresent invention, the close spacing of the electrodes facilitates theuse of low voltages.

In another example, to show that the embodiment of FIGS. 1-3 can be usedto effectively carry out electrolysis in saline solutions up to about 1%in concentration, the electrolysis reaction is carried out at salineconcentrations of 0.3, 0.6 and 0.9%, respectively. The active chlorinespecies (Cl₂) and ozone (O₃) contents were measured and are provided inTable B.

                  TABLE B                                                         ______________________________________                                        Cl.sub.2  and O.sub.3  Content from Salines at Varying Concentrations         Saline       Cl.sub.2                                                         Concentration                                                                              Concentration                                                                             O.sub.3 Concentration                                (% NaCl)     (ppm)       (mg/mL)                                              ______________________________________                                        0.3          129         21.8                                                 0.6          161         26.6                                                 0.9          168         28.0                                                 ______________________________________                                    

As can be seen from Table B, the resulting electrolyzed saline solutionincludes active components which are within the parameters required foreffective treatment.

It will be appreciated that the features of the present invention,including the close electrode spacing, the low voltages used, and thematerials used to fabricate the electrodes, result in an apparatus whichprovides unexpectedly better results than the previously availabledevices and schemes.

From the foregoing, it will be appreciated that the present inventionprovides an apparatus and method for electrolyzing saline solutionswhich are particularly suitable for administration in vivo and whichdoes not introduce harmful substances into the electrolyzed fluid. Thepresent invention also provides an apparatus and method forelectrolyzing saline solutions which is reliable and can be economicallyoperated.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed and desired to be secured by United States letterspatent is:
 1. An apparatus for electrolyzing fluids comprising:containermeans for holding a fluid for in vivo treatment of a patient, the fluidhaving a saline concentration of at least about 0.15% and the containermeans comprising a container fabricated from a biologically Compatiblematerial; power supply means for providing a source of electricalcurrent; a first anode connected to the power supply means, the anodecomprising a base, said base comprising a metal selected from the groupconsisting of platinum, titanium and niobium, said first anode furthercomprising an outer layer of platinum bonded to the base, the anodecomprising a cylindrical shape and positioned in the container meanssuch that the outer layer of the anode is immersed in any fluid held bythe container means; a first cathode connected to the power supplymeans, the cathode comprising a metal and a substantially cylindricalshape and positioned concentrically in relation to the anode, thespacing between the cathode and the anode being not greater than aboutone-half inch and the voltage potential between the cathode and theanode being not greater than about thirty volts when fluids are beingelectrolyzed therein; and means, associated with the power supply, foradjusting the voltage applied between the first anode and the firstcathode to a voltage which is less than about thirty volts.
 2. Anapparatus for electrolyzing fluids as defined in claim 1 furthercomprising:a second anode connected to the power supply means, thesecond anode comprising a base, said base comprising a metal selectedfrom the group consisting of titanium and niobium, said second anodefurther comprising an outer layer of platinum bonded to the base, thesecond anode comprising a cylindrical shape and positioned in thecontainer means such that the outer layer of the anode is completelyimmersed in any fluid held by the container means; and a second cathodeconnected to the power supply means, the second cathode comprising ametal selected from the group consisting of titanium and niobium and asubstantially cylindrical shape and positioned concentrically inrelation to the first anode and the first anode, the spacing between thesecond cathode and the second anode being not greater than aboutthree-eights inch and the voltage potential between the second cathodeand the second anode being not greater than about thirty volts whenfluids are being electrolyzed thereby.
 3. An apparatus for electrolyzingfluids as defined in claim 2 further comprising:a plurality of anodeseach connected to the power supply means, each of the plurality ofanodes comprising a base, said base comprising a metal selected from thegroup consisting of titanium and niobium, each of said plurality ofanodes further comprising an outer layer of platinum bonded to the base,the plurality of anodes each comprising a cylindrical shape andpositioned in the container means such that the outer layer of theplurality of anodes is completely immersed in any fluid held by thecontainer means; and a plurality of cathodes each connected to the powersupply means, the plurality of cathodes of a substantially cylindricalshape and positioned concentrically in relation to the first anode, thesecond anode, and the plurality of anodes, the spacing between each ofthe plurality of cathodes and the plurality of anodes being not greaterthan about three-eights inch and the voltage potential between each ofthe plurality of cathodes and the plurality of anodes being not greaterthan about thirty volts when fluids are being electrolyzed thereby. 4.An apparatus for electrolyzing fluids as defined in claim 1 wherein thefirst anode consists essentially of a base metal and an outer layer, thebase metal consisting essentially of niobium and the outer layerconsisting essentially of platinum and wherein the first cathodeconsists essentially of titanium.
 5. An apparatus for electrolyzingfluids as defined in claim 1 wherein the first anode consistsessentially of a base metal and an outer layer, the base metalconsisting essentially of niobium and the outer layer consistingessentially of platinum and wherein the first cathode consistsessentially of niobium.
 6. An apparatus for electrolyzing fluids asdefined in claim 1 wherein the fluid consists essentially of salinesolution.
 7. An apparatus for electrolyzing fluids as defined in claim 1wherein the container means further comprises a lid.
 8. An apparatus forelectrolyzing fluids as defined in claim 1 wherein the container meanscomprises a cylindrical container comprising a top portion and a bottomportion and wherein the first anode and the first cathode are positionedin the bottom portion of the container.
 9. An apparatus forelectrolyzing fluids as defined in claim 1 wherein the base consistsessentially of niobium.
 10. An apparatus for electrolyzing fluids asdefined in claim 1 wherein the base consists essentially of titanium.11. An apparatus for electrolyzing fluids as defined in claim 1 whereinthe first anode comprises an anode surface and the first cathodecomprises a cathode surface and the anode surface and the cathodesurface are substantially parallel.
 12. An apparatus for electrolyzingfluids as defined in claim 1 wherein the outer layer of platinumcomprises a layer of platinum having a thickness in the range from about0.02 mils to about 0.20 mils.
 13. An apparatus for electrolyzing fluidsas defined in claim 12 wherein the outer layer of platinum comprises alayer of platinum having a thickness of about 0.06 mils.
 14. Anapparatus for electrolyzing fluids as defined in claim 1 wherein thespacing between the cathode and the anode is not greater than aboutone-quarter inch.
 15. An apparatus for electrolyzing fluids as definedin claim 1 wherein the power supply comprises means for providing directcurrent.